Coles Theresa, Chen Kristina, Nelson Lauren, Harris Nimanee, Vera-Llonch Montserrat, Krasner Alan, Martin Susan
RTI Health Solutions, Research Triangle Park, NC, USA,
Shire Human Genetic Therapies, Lexington, MA, USA.
Patient Relat Outcome Meas. 2019 Jan 29;10:25-36. doi: 10.2147/PROM.S179310. eCollection 2019.
To conduct an initial psychometric evaluation of the reliability and validity of the Hypoparathyroidism Symptom Diary (HPT-SD).
Data were collected during a cross-sectional, observational study. Participants with self-reported hypoparathyroidism (HPT) completed the HPT-SD, the Functional Assessment in Cancer Therapy-Cognitive Function (FACT-Cog), the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), and the Hospital Anxiety and Depression Scale (HADS) measures. Item- and scale-level internal consistency reliability, known-groups validity, and construct validity were evaluated. Subscales were identified and preliminary scoring algorithms were developed.
The study included 52 participants (mean age, 51 years). Overall, the measurement properties of the HPT-SD were very good. Item-level response frequency distributions showed evidence of possible floor effects for four muscle-related symptom items. Inter-item correlations revealed a pattern of relationships among symptom items (=0.3-0.8) and among impact items (=0.5-0.7) and provided evidence for two HPT-SD subscales: Symptoms and Impacts. Construct validity correlations supported a priori convergent validity hypotheses (|r|≥0.4) between HPT-SD subscales and the FACT-Cog, FACIT-Fatigue, and HADS. Mean HPT-SD Symptom and Impact scores were in the expected direction and significantly different between subgroups of patients with high and low HPT disease severity.
Results indicate that the HPT-SD is an appropriate measure of HPT-related symptoms and impacts. Floor effects may be attributed to the observational study design: participants manage symptoms with calcium and active vitamin D supplements prior to an escalation in severity. Future studies should assess the HPT-SD measurement properties using longitudinal study designs.
对甲状旁腺功能减退症状日记(HPT-SD)的信度和效度进行初步心理测量学评估。
数据收集于一项横断面观察性研究。自我报告患有甲状旁腺功能减退(HPT)的参与者完成了HPT-SD、癌症治疗认知功能功能评估(FACT-Cog)、慢性病治疗疲劳功能评估(FACIT-疲劳)以及医院焦虑抑郁量表(HADS)测量。评估了项目和量表层面的内部一致性信度、已知群体效度和结构效度。确定了子量表并制定了初步评分算法。
该研究纳入了52名参与者(平均年龄51岁)。总体而言,HPT-SD的测量属性非常好。项目层面的反应频率分布显示,四个与肌肉相关的症状项目存在可能的地板效应证据。项目间相关性揭示了症状项目之间(=0.3 - 0.8)以及影响项目之间(=0.5 - 0.7)的关系模式,并为两个HPT-SD子量表提供了证据:症状和影响。结构效度相关性支持了HPT-SD子量表与FACT-Cog、FACIT-疲劳和HADS之间的先验收敛效度假设(|r|≥0.4)。HPT-SD症状和影响得分的平均值呈预期方向,且在HPT疾病严重程度高和低的患者亚组之间存在显著差异。
结果表明,HPT-SD是一种衡量HPT相关症状和影响的合适工具。地板效应可能归因于观察性研究设计:参与者在病情严重程度升级之前使用钙和活性维生素D补充剂来管理症状。未来的研究应使用纵向研究设计评估HPT-SD的测量属性。